Kornimate/medical-research-clean huggingface dataset:
side effects to folfoxiri + tocotrienol/placebo as first line treatment of metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: treatment with folfoxiri (5-fluorouracil, oxaliplatin, irinotecan) can be effective, but it has serious side effects, which may require hospitalization. the purpose of this study is to investigate whether the addition of tocotrienol can reduce the side effects to folfoxiri otherwise leading to hospitalization.


Eligibility criteria:
inclusion criteria: * histologically or cytologically verified colorectal adenocarcinoma. * patients to receive first line treatment of metastatic disease, including potentially resectable or non-resectable disease * \> 6 months without recurrence after end of adjuvant chemotherapy for radically treated stage ii or iii colorectal cancer * disease evaluable according to recist 1.1, but not necessarily measurable disease. * age 18-75 years * performance status (ps) 0-1. if age 71-75, then ps 0 * life expectancy \> 3 months * organ and bone marrow function as follows: * neutrophil count ≥ 1.5 x 10\^9/l * thrombocytes ≥ 100 x 10\^9/l * total bilirubin ≤ 1.5 x upper level of normal (uln) * alanine transaminase (alat) ≤ 2.5 x uln (or≤ 5 x uln in case of liver metastases) * fertile women must present negative pregnancy test. male (with a female fertile partner) as well as female patients must use secure contraceptives during and 6 months after end of treatment. * orally and written informed consent to treatment and biobank exclusion criteria: * primarily resectable metastases * chemotherapy, radiotherapy or immunotherapy within 4 weeks * known neuropathy ≥ grade 2 * serious competitive medical condition * other concurrent malignant disease other than non-melanoma skin cancer * previous serious and unexpected reactions to 5-fluorouracil, calcium folinate, oxaliplatin, irinotecan or capecitabine. * hypersensitivity to one or more of the active substances or auxilliary agents
safety study of dasatinib with bortezomib (velcade®) and dexamethasone for multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to determine the safety and tolerability of dasatinib with bortezomib in the treatment of relapsed or refractory multiple myeloma.


Eligibility criteria:
key inclusion criteria: * confirmed diagnosis of multiple myeloma with measurable disease * evidence of relapsed or refractory disease and at least 2 prior therapies for multiple myeloma * eastern cooperative oncology group performance status of 0 - 2 * last treatment for multiple myeloma not within 21 days prior to study treatment initiation * bone marrow transplant not within 3 months prior to study treatment initiation * required baseline hematology and chemistry parameters. key exclusion criteria: * clinically significant cardiac disease (new york heart association class iii or iv) * abnormal qt interval corrected for heart rate using fridericia's formula prolonged (\>450 msec) after electrolytes have been corrected on baseline electrocardiogram * malabsorption syndrome or uncontrolled gastrointestinal toxicities * dementia, chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation * clinically significant pleural effusion in the previous 12 months or current ascites * clinically significant coagulation or platelet function disorder * intolerance to dasatinib and/or bortezomib * acute diffuse infiltrative pulmonary disease * prior or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated stage i or ii cancer currently in complete remission, cervical carcinoma in situ, or any other cancer from which the participant has been disease-free for 3 years.
erythropoietin therapy for children with cerebral palsy: phase 1

Conditions: Cerebral Palsy

Summary: this purpose of this phase 1 study is to investigate the safety and efficacy of erythropoetin for children with cerebral palsy.

cerebral palsy is a disorder of movement and posture resulted from a nonprogressive lesion or injury of the immature brain. it is a leading cause of childhood onset disability. many experimental animal studies have revealed that erythropoietin is useful to repair neurological injury in brain. the main mechanism of erythropoietin is supposed as follows; neuroprotection effect, angiogenesis, and anti-inflammation. on the basis of many experimental studies, erythropoietin is suggested as a potential therapy for cerebral palsy.

Eligibility criteria:
inclusion criteria: * cerebral palsy * abnormal muscle tone * gmfcs (gross motor functional classification system): ii to iv * age: 6 months \~ 3 years * abnormal brain mri compatible to clinical features and non-progressive * willing to comply with all study procedure exclusion criteria: * known genetic disorder * baseline erythropoietin level \> 45 mu/ml * presence of drug hypersensitivity related to the study remedy * previous erythropoietin treatment before 3 months * coagulopathy: family history, unknown cerebral infarction, thromboembolic events history * intractable seizure disorder * poor cooperation of guardian including inactive attitude for rehabilitation * uncontrolled hypertension * liver dysfunction * renal dysfunction * absolute neutrophil count \< 500/dl * intracerebral or intraventricular hemorrhage * malignancy

Keywords: cerebral palsy erythropoietin rehabilitation
dyevert™ plus contrast reduction system multicenter observational study

Conditions: Chronic Kidney Disease

Summary: this is a prospective, single arm, multi-center, observational clinical study of the dyevert plus system. the dyevert plus system is an fda-cleared device designed to reduce contrast media volume delivered during angiography and permit real-time contrast media volume monitoring.

the purpose of this observational study is to evaluate the amount of contrast media saved using dyevert plus in coronary angiographic and/or interventional procedures performed with manual injection and evaluate the impact of predetermined thresholds and real-time monitoring.

Eligibility criteria:
inclusion criteria: * scheduled to undergo cag and/or pci * baseline estimated glomerular filtration rate (egfr) of ≥20 and ≤60 ml/ min/1.73 m2 exclusion criteria: * acute st-elevation myocardial infarction or known coronary artery fistulas * body mass index (bmi) \>40 * currently pregnant * undergoing a chronic total occlusion procedure or optical coherence tomography analysis * planning to undergo transcatheter aortic valve replacement within 72 hr of the index procedure * a condition known to require large volumes of contrast (\>10 ml) for each injection
the size of the gastric remnant as determinant for delayed gastric emptying after whipple resection.

Conditions: 50 % Reduction of Delayed Gastric Emptying

Summary: a small gastric remnant after whipple resection improves gastric emptying and therefore prevents the development of delayed gastric emptying.

every patient submitted to a whipple resection and at the same time present with characteristics suggestive of minimal risk for leakage from the pancreaticojejunostomy will be included in the study. at the time of reconstruction the patient will be randomized to either conventional size of the stomach or to a subtotal gastrectomy containing a small upper gastric pouch only.

Eligibility criteria:
inclusion criteria: all patients undergoing whipple procedure with preoperative assignment as low risk for leakage from the pancreaticojejunal anastomosis. * signed informed consent. exclusion criteria: * high and intermediate risk pancreaticojejunal anastomosis. unwillingness to participate.
transcultural validation in french of the systemic lupus activity questionnaire (slaq) and the lupus quality of life (lupusqol) questionnaire

Conditions: Lupus

Summary: the evaluation of lupus patients must include several approaches, in particular disease activity and quality of life. the systemic lupus activity questionnaire (slaq) is a validated self-questionnaire to evaluate disease activity. it has the advantage of being inexpensive, easy to use in large cohorts and has been used in several studies. it has never been validated in french. the lupus quality of life (lupusqol) is a self-questionnaire to evaluate quality of life and is specific to systemic lupus erythematous; it was developed from interviews with patients. this tool, validated in a british population, has never been validated in french.


Eligibility criteria:
inclusion criteria: * patients with lupus meeting the 1997 classification criteria of the american college of rheumatology for systemic lupus erythematous. * patients able to understand written and spoken french. * patients who have been informed about the research exclusion criteria: * severe mental retardation. * any impairment of ability to understand making self-evaluation impossible. * age \< 18 years. * age \> 75 years.
study to verify clinical utility of point-of-care (poc) thyroid stimulating hormone (tsh) test kits as compared to third generation tsh test kit

Conditions: Hypothyroidism

Summary: this is a phase 4, single-center, open-label, interventional study, wherein all enrolled subjects will be tested for thyroid stimulating hormone (tsh) by using the quantitative and the qualitative point-of-care (poc) tsh test kits and the third generation tsh test kit at the same time.


Eligibility criteria:
inclusion criteria: * suspected hypothyroidism subject * willing to comply with the trial protocol * signed informed consent document exclusion criteria: * menstrual period, bleeding hemorrhoids, hematuria * drinking or taking aspirin within 48 hours * subjects with partially or completely restricted consciousness and behavioral ability, who do not have independent decision-making ability. * subjects who are unwilling or unable to complete the trial * subjects who do not sign informed consent form

Keywords: hypothyroidism third generation tsh kit quantitative poc tsh kit qualitative poc tsh kit
passive stretching versus electrical stimulation on glucose level, in elderly with type ii diabetes

Conditions: Type II Diabetes

Summary: sixty elderly diabetics (type ii) their age ranged from 60-75 years had been divided into two equal groups; group (a) treated by 40-minute passive stretching exercises, while the group (b) treated by 30 minutes electrical stimulation three times per week for 12 weeks. blood glucose level,time up and go test (tug) and fatigue severity scale were done before and after 12 weeks of the study.conclusion: both electrical stimulation and passive stretching are effective to lowering blood glucose level and can be proposed for those people restricted to perform exercise.

background: physical exercise is one of the bases for controlling and treatment type 2 diabetes mellitus. but not all diabetic elderly is able to perform physical exercise because of their physical limitation condition. the approach for those people in this study is electrical stimulation and passive stretching. purpose: the aim of this study is to compare the effect of passive stretching and electrical stimulation on blood glucose level, functional mobility and perceived-fatigue in diabetic elderly. methods: sixty elderly diabetics (type ii) their age ranged from 60-75 years had been divided into two equal groups; group (a) treated by 40-minute passive stretching exercises, while the group (b) treated by 30 minutes electrical stimulation three times per week for 12 weeks. blood glucose level,time up and go test (tug) and fatigue severity scale were done before and after 12 weeks of the study.

Eligibility criteria:
inclusion criteria: * hba1c value between 6.5% -8.5%, * age ranged from 60-75 years patients have * body mass index (bmi) from 25 to 29.9 kg/m2, * duration of diabetes ranged from 5-7 years. they were * on oral hypoglycemic medications at the same dose. * all patients were clinically and medically stable when attending the study. exclusion criteria: * unstable cardiovascular, * chest problems * other types of diabetes * on insulin therapy * chronic renal failure and * iron deficient anemia and * musculoskeletal disorders which may affect their physical ability to do the exercises.

Keywords: blood glucose electrical stimulation lower extremities passive stretching exercise
safety and efficacy of combigan® ophthalmic solution in korea

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: this study is a post-marketing surveillance study in korea to evaluate the safety and efficacy of combigan® (brimonidine tartrate/timolol maleate) ophthalmic solution in patients with open angle glaucoma or ocular hypertension with insufficient response to local beta blockers treated as per standard of care in clinical practice.


Eligibility criteria:
inclusion criteria: * patients with open angle glaucoma or ocular hypertension treated with combigan® ophthalmic solution as standard of care in clinical practice. exclusion criteria: * none.
study for evaluating different methods of measuring depression treatment response

Conditions: Depressive Disorder, Major

Summary: purpose of the study is to evaluate use of electronic diaries and voice acoustics for use in future depression clinical trial. focus is on increased precision of measurement.


Eligibility criteria:
inclusion criteria: * primary diagnosis of major depressive disorder with symptoms of depression present at least 1 month * psychotropic medications currently not being taken exclusion criteria: * failure to respond in past 5 years to antidepressant therapy of adequate duration and dosing * diagnoses of following conditions or disorders within past 6 months: generalized anxiety, obsessive compulsive, panic, post stress, anorexia, bulimia, alcohol or substance abuse or social anxiety disorder * diagnoses current or past of the following conditions or disorders: schizophrenia, psychotic disorder, delieium, dememtia, amnestic cognitive disorder, bipolar
combined effect of underwater ultrasound

Conditions: Rheumatoid Arthritis of Ankle; Ultrasound Therapy; Complications

Summary: this randomised controlled trial aims to investigate the effects of underwater ultrasound therapy and customised foot insoles in ra patients. the study evaluates the effects of the combined use of these two methods on pain, functional status and quality of life. the research aims to contribute to current treatment approaches and to demonstrate the effectiveness of innovative methods to improve the quality of life of ra patients.

rheumatoid arthritis (ra) is a chronic inflammatory disease that can cause pain, swelling, limitation of movement and deformities in the joints (cabrera-sánchez et al. 2024)(cabrera-sánchez et al. 2024). foot and ankle involvement is quite common in ra patients and this may adversely affect the daily living activities of patients. in addition to pharmacological approaches, physical therapy methods and the use of biomechanical supports are also important in the treatment of ra. ultrasound is a physical therapy method used to reduce pain and inflammation and accelerate tissue healing (király et al. 2021). underwater ultrasound applications may be more effective in superficial areas and may reduce the risk of damage to sensitive tissues around the joint. on the other hand, customised foot insoles (orthotics) are frequently used to correct foot deformities, eliminate biomechanical imbalances and reduce pain (gaino et al. 2021). this randomised controlled trial aims to examine the effects of underwater ultrasound therapy and customised foot insoles in ra patients. the study evaluates the effects of the combined use of these two methods on pain, functional status and quality of life. the research aims to contribute to current treatment approaches and to demonstrate the effectiveness of innovative methods to improve the quality of life of ra patients.

Eligibility criteria:
inclusion criteria: * - acr/eular 2010 diagnostic criteria with foot involvement and having a disease duration of less than two years were enrolled in the study over a period of three months. * with foot involvement diagnosed by a rheumatologist. exclusion criteria: * - degenerative diseases and anatomical abnormalities were excluded * if they presented in an acute symptomatic flare or they needed to use walking assistance * neurological problems, malignant process, cognitive deterioration, pregnancy, previous foot surgery and the presence of a foot wound
an open-label study to evaluate the intraduodenal delivery of enzymes from administration of viokase16 in exocrine pancreatic insufficiency (epi)

Conditions: Exocrine Pancreatic Insufficiency

Summary: epi leading to maldigestion is a frequent finding in many diseases of the pancreas, such as chronic pancreatitis (cp). steatorrhea is the most important digestive manifestation in epi. the current treatment of epi includes enzyme supplementation with porcine pancreatic enzyme concentrate, consisting mainly of lipase, amylase and protease. an enzyme preparation able to deliver appropriate enzyme levels to the duodenum instead of the mid gut or distal small bowel, would appear to be clinically efficacious for the treatment of steatorrhea in subjects with cp suffering from epi.

day of screening: subjects will undergo screening procedures prior to entry into the study. day 0: subjects will be admitted to the facility. day 1: subjects will undergo a first perfusion/aspiration procedure. day 2: subjects will rest. day 3: subjects will undergo a second perfusion/aspiration procedure. day 4: subjects will be discharged.

Eligibility criteria:
inclusion criteria: * subjects must have the ability to give informed consent * female subjects must use a medically acceptable form of birth control and have a negative pregnancy test upon entering the study and not be breast-feeding * subjects must have medical condition compatible with exocrine pancreatic insufficiency * subjects must be off therapeutic doses of pancreatic enzyme supplementation prior to study entry day * subjects must be on omeprazole at least 5 days prior day 0. exclusion criteria: * subjects with a known hypersensitivity and/or contraindication to viokase®16 or to any non-active component of viokase or to any protein of porcine origin * subjects with a known hypersensitivity and/or contraindication to omeprazole or to any non-active component of omeprazole * subjects on enzyme therapy, h2-receptor antagonists, anticholinergics, antispasmodics prior to study entry * female subjects who are pregnant or lactating * subjects with acute pancreatitis or acute exacerbations of chronic pancreatic disease * subjects with a history of solid organ transplant or significant bowel resection between esophagus and pancreas * subjects who have received an investigational new drug within 30 days prior to entry into the study. * subjects with a known coagulopathy * subjects with any abnormal liver function test * subjects known to have a significant medical and/or mental disease that would compromise the subject's welfare or confound the study results * subjects who are not on omeprazole at least 5 days prior day 0

Keywords: enzymes viokase bioavailability
expanded access 68gallium-psma-11 pet for prostate cancer

Conditions: Prostate Cancer; Prostate; Prostate Adenocarcinoma

Summary: this expanded access protocol provides eligible participants with investigational 68ga-psma-11 pet imaging to detect and localize prostate cancer for initial and subsequent treatment strategy.


Eligibility criteria:
biochemical recurrent and pre-prostatectomy staging participants will be eligible and must meet the following criteria: inclusion criteria: 1. age ≥ 18 years 2. histopathologically confirmed or biopsy proven prostate adenocarcinoma. 3. concern for metastatic disease in one of the following settings: 1. initial staging with intermediate to high risk prostate cancer. 2. biochemical recurrence after initial therapy. 4. ability to understand a written informed consent document, and the willingness to sign it exclusion criteria: 1. unlikely to comply with protocol procedures, restrictions and requirements and judged by the investigator to be unsuitable for participation
thermocool® smarttouch™ registry

Conditions: Symptomatic Atrial Fibrillation

Summary: the primary purpose of this registry is to obtain "real world" clinical use of contact force measurements during ablation procedures.


Eligibility criteria:
inclusion criteria: * subjects with symptomatic atrial fibrillation (af) who, in the opinion of the investigator, are candidates for ablation for atrial fibrillation. candidates who have had previous ablation procedures may be included in the registry * subjects who have failed at least one antiarrhythmic drug (aad)(class i or iii, or av nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic atrial fibrillation, or intolerable to the aad. * subjects must be 18 years of age or older * subjects must be able and willing to comply with all pre-, post and follow-up testing and requirements * subjects must provide written informed consent to participate in the registry exclusion criteria: * significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this registry * history of blood clotting or bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran) * history of a documented thromboembolic event within the past year * significant pulmonary disease (eg, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease)or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms * previous cardiac surgery (eg, cabg) or valvular cardiac surgical procedure (eg, ventriculotomy, atriotomy, valve repair or replacement, presence of a prosthetic valve) * awaiting cardiac transplantation or other cardiac surgery within the next 360 days (12 months) * diagnosed atrial myxoma * unstable angina * uncontrolled heart failure uncontrolled heart failure or nyha class iii or iv heart failure * acute illness, active systemic infection, or sepsis * any other disease or malfunction that would preclude treatment with ablation in the opinion of the investigator